Hydrocodone extended-release capsules

Pronunciation

Generic Name: hydrocodone (HYE-droe-KOE-done)
Brand Name: Zohydro ER

Hydrocodone extended-release capsules is a narcotic pain medicine that may become habit-forming. Misuse or abuse can lead to overdose and death. Do NOT take more than the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.

Hydrocodone extended-release capsules may cause severe and sometimes fatal breathing problems. The risk may be greater when you first start this drug or with any increase in dose. Contact your doctor right away if you experience slow, shallow, or difficult breathing.

Be sure to swallow hydrocodone extended-release capsules whole. Do NOT break, crush, cut, dissolve, or chew hydrocodone extended-release capsules before swallowing it. Do NOT inject hydrocodone extended-release capsules. Doing any of these things could result in very serious side effects, including severe trouble breathing and death from overdose.

Accidental swallowing of hydrocodone extended-release capsules may be fatal, especially in children. Keep hydrocodone extended-release capsules out of the reach of children. Seek emergency medical care right away if another person swallows hydrocodone extended-release capsules.

Long-term use of hydrocodone extended-release capsules during pregnancy may cause dependence in the unborn baby. This can lead to withdrawal in the newborn, which can be life-threatening. Discuss any questions or concerns with your doctor.

Do not drink alcohol or take medicines (prescription or nonprescription) that contain alcohol while you are taking hydrocodone extended-release capsules. Alcohol may increase the amount of hydrocodone extended-release capsules in your body and could cause death from overdose.


Hydrocodone extended-release capsules is used for:

Managing severe pain when continuous (around-the-clock) treatment is needed for an extended period of time. Hydrocodone extended-release capsules is not for use if only occasional or "as-needed" pain relief is needed.

Certain strengths of hydrocodone extended-release capsules should only be used by patients who have already been taking other narcotic pain medicine on a regular schedule and are tolerant to its effects. The use of these strengths by people who are not used to taking narcotic pain medicine may cause severe and sometimes fatal breathing problems.

Hydrocodone extended-release capsules is a narcotic (opioid) pain medicine. It works in the brain and nervous system to reduce pain.

Do NOT use hydrocodone extended-release capsules if:

  • you are allergic to any ingredient in hydrocodone extended-release capsules
  • you have narrowing of the stomach or bowels or known or suspected stomach or bowel blockage (eg, paralytic ileus)
  • you have severe lung problems (eg, severe asthma); slow, shallow, or difficult breathing; or high levels of carbon dioxide in the blood (hypercarbia), or you are having an asthma attack
  • you are taking mixed agonist/antagonist pain medicines (eg, buprenorphine, butorphanol, nalbuphine, pentazocine) or sodium oxybate (GHB)
  • you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

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Before using hydrocodone extended-release capsules:

Some medical conditions may interact with hydrocodone extended-release capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, especially other narcotic pain medicines (eg, morphine, hydromorphone); foods; or other substances
  • if you have a history of chronic obstructive pulmonary disease (COPD) or other lung or breathing problems (eg, asthma, emphysema, bronchitis), sleep apnea, curvature of the spine (scoliosis), a certain heart problem (cor pulmonale), high levels of carbon dioxide in the blood (hypercapnia or hypercarbia), or low levels of oxygen in the blood (hypoxia)
  • if you have severe drowsiness, a recent head injury, increased pressure in the brain, growths in the brain (eg, tumors, lesions), or a history of seizures
  • if you have a history of liver problems, kidney problems, thyroid problems, gallbladder problems, pancreas problems (eg, pancreatitis), urinary blockage or trouble urinating, an enlarged prostate, or stomach or bowel problems (eg, blockage, inflammation)
  • if you have difficulty swallowing, constipation, low blood pressure, dehydration, low blood volume, poor health, or stomach pain
  • if you drink alcohol, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts
  • if you or a member of your family has a history of mood or mental problems (eg, depression), or alcohol or other substance abuse or dependence
  • if you are very overweight or have recently had or will be having surgery (eg, stomach or bowel surgery)

Some MEDICINES MAY INTERACT with hydrocodone extended-release capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased
  • Sodium oxybate (GHB) because the risk of severe drowsiness, coma, confusion, or slowed or difficult breathing may be increased
  • Anticholinergics (eg, benztropine, scopolamine) because the risk of constipation and trouble urinating may be increased
  • Azole antifungals (eg, ketoconazole), macrolide antibiotics (eg, erythromycin), MAOIs (eg, phenelzine), other narcotic pain medicines (eg, codeine, morphine), protease inhibitors (eg, boceprevir, ritonavir), or telithromycin because they may increase the risk of hydrocodone extended-release capsules's side effects
  • Carbamazepine, phenytoin, or rifamycins (eg, rifampin) because they may decrease hydrocodone extended-release capsules's effectiveness
  • Mixed agonist/antagonist pain medicines (eg, buprenorphine, butorphanol, nalbuphine, pentazocine) or naltrexone because they may decrease hydrocodone extended-release capsules's effectiveness and withdrawal may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if hydrocodone extended-release capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use hydrocodone extended-release capsules:

Use hydrocodone extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Hydrocodone extended-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get hydrocodone extended-release capsules refilled.
  • Take hydrocodone extended-release capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Hydrocodone extended-release capsules must only be taken by mouth. Do not snort or inject hydrocodone extended-release capsules.
  • Swallow hydrocodone extended-release capsules whole. Do not break, cut, crush, chew, open, or dissolve the capsule before swallowing it. Take 1 capsule at a time if your dose calls for more than 1 capsule. Take each capsule with enough water to be sure that you swallow it completely. Swallow hydrocodone extended-release capsules immediately after you place it in your mouth. If you cannot swallow hydrocodone extended-release capsules whole, tell your doctor.
  • Do not suddenly stop taking hydrocodone extended-release capsules. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop hydrocodone extended-release capsules, your doctor will gradually lower your dose.
  • Hydrocodone extended-release capsules works best if it is taken at the same time(s) each day. Do not miss any doses.
  • If you miss a dose of hydrocodone extended-release capsules, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than 1 dose in 12 hours.

Ask your health care provider any questions you may have about how to use hydrocodone extended-release capsules.

Important safety information:

  • Hydrocodone extended-release capsules may cause dizziness, drowsiness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use hydrocodone extended-release capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or take medicines (prescription or nonprescription) that contain alcohol while you are taking hydrocodone extended-release capsules. Check with your pharmacist if you have questions about whether any of your medicines contain alcohol.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking hydrocodone extended-release capsules; the risk of low blood pressure, severe drowsiness or breathing problems may be increased. Ask your pharmacist if you have questions about which medicines may increase the risk of these effects.
  • Hydrocodone extended-release capsules may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Hydrocodone extended-release capsules may cause constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking hydrocodone extended-release capsules, talk with your doctor or pharmacist.
  • Do NOT take more than the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.
  • If your pain continues or becomes worse or if you have side effects that concern you, contact your doctor.
  • Tell your doctor or dentist that you take hydrocodone extended-release capsules before you receive any medical or dental care, emergency care, or surgery.
  • Seek emergency medical care right away if another person swallows hydrocodone extended-release capsules. Accidental swallowing of hydrocodone extended-release capsules may be fatal, especially in children.
  • Use hydrocodone extended-release capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems, confusion, and drowsiness.
  • Hydrocodone extended-release capsules should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY AND BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using hydrocodone extended-release capsules while you are pregnant. Long-term use of hydrocodone extended-release capsules during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. Hydrocodone extended-release capsules is found in breast milk. Do not breast-feed while taking hydrocodone extended-release capsules.

When used for long periods of time or at high doses, hydrocodone extended-release capsules may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if hydrocodone extended-release capsules stops working well. Do not take more than prescribed.

Some people who use hydrocodone extended-release capsules for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you suddenly stop taking hydrocodone extended-release capsules, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of hydrocodone extended-release capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; headache; mild stomach pain; nausea; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); burning, numbness, or tingling; chest pain; confusion; difficult or painful urination; fainting; fast, slow, or irregular heartbeat; fever or chills; memory problems; mental or mood changes (eg, agitation, anxiety, depression); muscle pain, weakness, or cramping; severe or persistent dizziness, drowsiness, or light-headedness; severe or persistent stomach pain, constipation, or vomiting; shortness of breath; slow, difficult, or shallow breathing; swelling of the hands, ankles, or feet; tremor; trouble sleeping.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of hydrocodone extended-release capsules:

Store hydrocodone extended-release capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep hydrocodone extended-release capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about hydrocodone extended-release capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Hydrocodone extended-release capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take hydrocodone extended-release capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about hydrocodone extended-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to hydrocodone extended-release capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using hydrocodone extended-release capsules.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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